Oncology

Condition or Disease Phase Site
Metastatic Prostate Cancer Phase 1 1 Site
Selected advanced/metastatic solid tumors Phase 1 12 Sites
Locally Advanced Unresectable Pancreatic Adenocarcinoma Phase 1 4 Sites
Non-small Cell Lung Cancer Prostate Cancer Renal Cancer Transitional Cell Carcinoma Phase 1/2 5 Sites
Breast Cancer Phase 2 Multiple Sites
Breast Cance Phase 2 Multiple Sites
Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck Phase 2 35 Sites
Multiple Solid Tumor Phase 2 24 Sites
Cutaneous melanoma Phase 3 Multiple Sites
Stage I-III melanoma Phase 3 Multiple Sites
Cervical Intraepithelial Neoplasia Grade 2/3 Phase 3 Multiple Sites
Breast Cancer Phase 3 Multiple Sites
Non-Small Cell Lung Cancer Phase 3 NA
Breast Cancer NA NA

Ophthalmology

Condition or Disease Phase Site
Visumax Femtosecond Laser to Perform SMILE Optimized For Presbyopia PMA Multiple Sites
Cataract Cataract-VirtIOL PMA Multiple Sites
Primary Open-angle Glaucoma PMCF 4 Sites
Cataract PMCF Multiple Sites
Cataract Senile PMCF Multiple Sites
Cataract Senile PMCF Multiple Sites
Cataract Senile PMCF Multiple Sites
Cataract Senile PMCF Multiple Sites
Cataract Senile PMCF Multiple Sites
Cataract Senile PMCF Multiple Sites
Cataract Senile PMCF Multiple Sites
Cataract Senile OVD-PROMIZ PMCF Multiple Sites
Cataract Senile OVD-KEA PMCF NA
Survey-RT Decalin Surgery Multiple Sites
Note:
PMA = Pre-Market Approval; PMCF = Post-Market Clinical Follow-up

Immunology

Condition or Disease Phase Site
Inflammatory Phase 1 NA
Reconstitution of a severely impaired immune system Phase 1 1 Site
Allergic rhinoconjunctivitis Phase 2 Multiple Sites
Active Rheumatoid Arthritis Phase 2 1 Site
Acute Graft Versus Host Disease in Intestine Steroid Refractory GVHD Phase 3 39 Sites
Severe Rheumatoid Arthritis Phase 3 Multiple Sites
Acute Graft Versus Host Disease Phase 4 NA
Acute Graft Versus Host Disease in Intestine Steroid Refractory GVHD Phase 4 NA

Hematology

Condition or Disease Phase Site
Acute Myeloid Leukemia Phase 1 7 Sites
AML and MDS patients failing or being refractory to hypomethylating agent (HMA)-based treatment Phase 2 12 Sites
Beta Thalassemia Major Anemia Phase 2 Multiple Sites
Multiple Myeloma Phase 2 Multiple Sites
Hypofibrinogenaemia Phase 3 NA

Infections and Infestations Disorders

Condition or Disease Phase Site
COVID-19 Observation Multiple Sites
COVID-19 PMCF 1 Site
Bacterial vaginosis PMCF Multiple Sites
COVID-19 Phase 2 40 Sites
COVID-19 Phase 2 Multiple Sites
COVID-19 Phase 3 NA
Chikungunya Phase 3 NA
Note:
PMCF = Post-Market Clinical Follow-up

Dermatology

Condition or Disease Phase Site
Chronic Wounds (e.g. pressure, venous leg and diabetic foot ulcers) PMCF 1 Site
Venous Leg Ulcer PMCF 3 Sites
Skin perception after intradermal application of IncobotulinumtoxinA Phase 2 1 Site
Thermal Burns Phase 3 29 Sites
Bilateral Blepharospasm Phase 3 11 Sites
Atopic Dermatitis Phase 3 87 Sites
Psoriasis Phase 3 Multiple Sites
Chronic Hand Eczema Phase 3 Multiple Sites
Alopecia Phase 4 NA
Note:
PMCF = Post-Market Clinical Follow-up

Endocrinology

Condition or Disease Phase Site
Osteoporosis PMCF NA
Cannabidiol Phase 2 NA
Eosinophilic Gastroenteritis Phase 3 Multiple Sites
Testosterone Gel Hypogonadal Phase 3 NA
Postmenopausal Osteoporosis Phase 3 76 Sites
Diabetes Phase 3 NA

Neurology

Condition or Disease Phase Site
Complaints and Pain PMCF NA
Serious mental illness PMCF 1 Site
Chronic Pain Phase 1 1 Site
Parkinson Disease Phase 2 Multiple Sites
Progressive Supranuclear Palsy Phase 2a Multiple Sites
Epilepsy Phase 3 87 Sites
Aicardi-Goutières Syndrome Phase 3 Multiple Sites
Alzheimer Phase 3 Multiple Sites
Note:
PMCF = Post-Market Clinical Follow-up

Hepatology

Condition or Disease Phase Site
Liver Failure Phase 2a NA
Primary Biliary Cholangitis Liver Stiffness Phase 2b 80 Sites

Urology and Nephrology

Condition or Disease Phase Site
Removal of kidney stones PMCF 10 Sites
Female Sexual Arousal Phase 2 Multiple Sites
Note:
PMCF = Post-Market Clinical Follow-up

Stomatology

Condition or Disease Phase Site
Caries AI Detection (FDA 510k) PMA Multiple Sites
Bone Landmarks Detection AI Detection (FDA 510k) PMA Multiple Sites
Note:
PMA = Pre-Market Approval

Ultrasonography

Condition or Disease Phase Site
Obstetric Ultrasonography AI Detection (FDA 510k) PMA NA
Note:
PMA = Pre-Market Approval